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NCT04802343
A Trial to Learn How BAY1817080 Moves Into, Through and Out of the Body and How Safe it is in Healthy Chinese Men
Phase 1 trial testing BAY1817080 in Healthy Volunteers in 39 participants. Completed in 29 October 2021.
19 July 2021
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 39 |
| Start date | 2 April 2021 |
| Primary completion | 19 July 2021 |
| Estimated completion | 29 October 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- BAY1817080 — full drug profile →
- Placebo
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 45, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Researchers are looking for a better way to treat chronic cough. Before patients with medical conditions can join clinical trials, researchers do trials in healthy participants first to understand how the body acts on the new treatment and learn how safe it is. In this trial, the researchers will study how much of the trial drug, BAY1817080, gets into the blood in a small number of participants. The trial will include about 39 healthy Chinese male who are aged 18 to 45. For this trial participants will be divided in 3 groups. Groups 1 and 2 will take either dose 1 or dose 2 of BAY1817080 or placebo 1 time. Participants of groups 3 will take dose 3 of BAY1817080 or placebo one time at the first day and continue to take dose 3 of BAY1817080 twice a day from day 7 to day 16 of the trial. On day 17 they will take only one dose 3 of BAY1817080. All participants will take BAY1817080 or a placebo as a tablet by mouth. For this trial, the participants in Groups 1 and 2 will stay at the trial site for up to 10 days. The participants in Group 3 will stay at the trial site for up to 26 days. The trial will last up to 4 weeks for the participants in Groups 1 and 2, and 6 weeks for the participants in Group 3. During the trial, the doctors will take blood and urine samples and check the participants blood pressure, pulse rate and electrocardiogram (ECG). The participants will answer questions about how they are feeling to check their general wellbeing.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
P2X3 Receptor Antagonist Eliapixant in Phase I Clinical Trials: Safety and Inter-ethnic Comparison of Pharmacokinetics in Healthy Chinese and Japanese Participants.
Li X, Haranaka M, Li H, Liu P, et al · · 2024 · PMID 38907175 · DOI 10.1007/s40262-024-01387-y
Verify or expand the search:
- PubMed search for NCT04802343
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BAY1817080
Trials testing the same drug.
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- NCT04641273 — A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants Wit · Phase 2 · terminated
- NCT04562155 — Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patient · Phase 2 · completed
- NCT04545580 — Clinical Study to Evaluate the Treatment Effect and Safety of BAY1817080 in Patients With Overactive Bladder (OAB) · Phase 2 · completed
- NCT04471337 — Study on the Safety of BAY1817080 How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Stud · Phase 1 · completed
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04802343 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 19 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04802343.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing